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CTRI Number  CTRI/2021/01/030299 [Registered on: 06/01/2021] Trial Registered Prospectively
Last Modified On: 05/01/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Effect of Metabolic Syndrome on Osteoarthritis Knee 
Scientific Title of Study   Association Of Metabolic Syndrome With Pain Intensity In Patients Of Osteoarthritis Knee 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rachit Gulati 
Designation  Senior Resident 
Affiliation  Department of Physical Medicine and Rehabilitation, AIIMS, Bhopal 
Address  Department of Physical Medicine and Rehabilitation, AIIMS, Bhopal
Department of Physical Medicine and Rehabilitation, AIIMS, Bhopal
Bhopal
MADHYA PRADESH
462020
India 
Phone  09829338844  
Fax    
Email  rachitgulati19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rachit Gulati 
Designation  Senior Resident 
Affiliation  Department of Physical Medicine and Rehabilitation, AIIMS, Bhopal 
Address  Department of Physical Medicine and Rehabilitation, AIIMS, Bhopal
Department of Physical Medicine and Rehabilitation, AIIMS, Bhopal
Bhopal
MADHYA PRADESH
462020
India 
Phone  09829338844  
Fax    
Email  rachitgulati19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sandeep Kumar Gupt 
Designation  Senior Resident 
Affiliation  Department of Physical Medicine and Rehabilitation, AIIMS, Bhopal 
Address  Department of Physical Medicine and Rehabilitation, AIIMS, Bhopal
Department of Physical Medicine and Rehabilitation, AIIMS, Bhopal
Bhopal
MADHYA PRADESH
462020
India 
Phone  09829338844  
Fax    
Email  drsandeep2k4@gmail.com  
 
Source of Monetary or Material Support  
Institute for Blood Testing Department of Pathology All India Institute of Medical Sciences, Bhopal-462020 
 
Primary Sponsor  
Name  AIIMS BHOPAL 
Address  AIIMS Saket Nagar Bhopal 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rachit Gulati  Department of Physical Medicine and Rehabilitation, AIIMS Bhopal  All India Institute of Medical Scineces Saket Nagar Bhopal
Bhopal
MADHYA PRADESH 
09829338844

rachitgulati19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Bhopal Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Age ≥ 18 years.
2. Patients must satisfy the American College of Rheumatology (ACR) Clinical Classification Criteria for Osteoarthritis of the knee8
3. Presence of knee pain for three or more months.
4. Kellgren-Lawrence Grade for assessment of OA knee grade 1,2 and 3 
 
ExclusionCriteria 
Details  1. Recent Medical Infections
2. Current/Previous Joint infections
3. Other inflammatory joint disease (like Rheumatoid Arthritis)
4. Co-morbid Autoimmune disease
5. All cases of secondary OA
6. Previous interventions or surgery in Knee Joint
7. Previous/current history of trauma to knee joint
8. Kellgren-Lawrence Grade for assessment of OA knee grade 4 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Metabolic Syndrome has positive correlation with Osteoarthritis Knee Pain   6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Metabolic Syndrome is prevalent in Osteoarthritis Knee patients  6 months 
 
Target Sample Size   Total Sample Size="95"
Sample Size from India="95" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Osteoarthritis (OA) of the knee is a common chronic joint disease characterized by pain and significant restrictive disability due to gradual deterioration and inflammation of the articular cartilages. Overall prevalence of knee osteoarthritis in India is 28.7% with common risk factors being female gender, obesity, age and sedentary work.1 The pathophysiologic mechanisms of OA are under debate, but there is general agreement that biomechanics and increased dynamic loading of the joint are involved.2 However genetic, metabolic, and neuroendocrine factors have also been implicated in increased incidence of OA knee.3
It has been recently suggested that there is a chronic low grade systemic inflammation in OA knee which has led some authors to consider osteoarthritis to be part of a greater inflammatory metabolic syndrome.4 Metabolic Syndrome (MetS) comprises a number of conditions, including central obesity, atherogenic dyslipidemia, impaired fasting glucose and hypertension (HTN). It is prevalent in 33.5% Indians (24.9% males and 42.3% females).5 Obesity, besides causing higher mechanical load on knee joint, is also thought to be related to excessive proinflammatory cytokine production which could play a pathophysiologic role in OA .6 The atherogenic effects related to hypertension can also change the microvasculature of sub-chondral bone, thus leading to development of OA changes.7
However, despite the high prevalence of both MetS and OA knee in Indian population, there are limited studies regarding the association between these two and effect of MetS on the pain intensity of patients with OA knee. Therefore we have planned to conduct this study to determine the association between OA knee, MetS (and its various parameters) and Pain intensity (Visual Analogue Score) in a population based study of a sample of Indian Population (Rural and Urban) visiting a tertiary care hospital in Bhopal.
 
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